Full Press Release Details
Pelthos Therapeutics Announces Third
Quarter Fiscal 2025 Financial Results
Conference call scheduled for
November 13, 2025 at 8:00am ET
Commercial launch of ZELSUVMI,
the first FDA-approved at-home molluscum contagiosum treatment, exceeded expectations and generated $7.1 million in net revenues
2,716 ZELSUVMI units prescribed
prescribers in the third quarter
DURHAM, N.C., November 13, 2025 -
Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic
products for unmet patient needs ("Pelthos" or the "Company"), today announced its financial results for
the three and nine months ended September 30, 2025, which can be found at the Financial Results section of the Company's
Third Quarter and Recent Highlights
Management Commentary
Scott Plesha, CEO of Pelthos commented,
"We are delighted with the commercial launch of ZELSUVMI in our first quarter as a merged company. The launch metrics, revenue
growth and gross to net discounts have exceeded our expectations. We anticipate strong continued growth for ZELSUVMI in Q4 2025,
as evidenced by the 2,189 units prescribed in October alone. The market uptake during the first quarter of ZELSUVMI's launch
demonstrates enthusiastic adoption by physicians and strong demand from patients and caregivers, clearly addressing a significant
unmet need. Our commercial operations and newly launched marketing programs will further educate healthcare providers, parents
and caregivers, as this product represents a significant shift in the treatment paradigm for molluscum contagiosum."
"In addition, the acquisition of
XEPI has added a second highly complementary product to our portfolio. FDA-approved XEPI treats an infectious skin condition primarily
impacting children, which aligns with the same target market as ZELSUVMI. This presents our sales reps and Pelthos with a synergistic
opportunity to increase revenue by leveraging our current commercial relationships and infrastructure. Although it is still early
days, Pelthos is well-positioned to capitalize on the large addressable markets and unmet needs presented by these two products."
Third Quarter 2025 Financial Summary (three months ended
Summary Financial Statements
Pelthos Therapeutics Inc.
Selected Condensed Consolidated Balance Sheet Data
| September 30, 2025 | December 31, 2024 | |||||||
| Cash and cash equivalents | $ | 14,203 | $ | 513 | ||||
| Accounts receivable, net | 7,988 | - | ||||||
| Inventory, net | 24,096 | - | ||||||
| Accounts payable | 5,666 | 1,897 | ||||||
| Accrued expenses | 11,890 | - | ||||||
| Total current assets | $ | 49,761 | $ | 1,369 | ||||
| Total assets | 126,433 | 1,369 | ||||||
| Total current liabilities | 24,768 | 4,083 | ||||||
| Total liabilities | 68,180 | 4,083 | ||||||
| Total stockholders' equity (deficit) | 58,253 | (2,714 | ) |
Pelthos Therapeutics Inc.
Condensed Consolidated
Statements of Operations
(in thousands except share and per share data)
| For the Three months Ended September 30, | For the Nine months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Net product revenues | $ | 7,112 | $ | - | $ | 7,112 | $ | - | ||||||||
| License and collaboration revenues | 294 | - | 294 | - | ||||||||||||
| Total revenue | 7,406 | - | 7,406 | - | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of goods sold | 2,316 | - | 2,316 | - | ||||||||||||
| Selling, general and administrative | 19,628 | 1,634 | 23,984 | 4,853 | ||||||||||||
| Research and development | 145 | 415 | 854 | 894 | ||||||||||||
| Amortization of intangible assets | 679 | - | 679 | - | ||||||||||||
| Total operating expenses | 22,768 | 2,049 | 27,833 | 5,747 | ||||||||||||
| Operating loss | (15,362 | ) | (2,049 | ) | (20,427 | ) | (5,747 | ) | ||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (1,346 | ) | (39 | ) | (1,698 | ) | (678 | ) | ||||||||
| Interest income and other income | 5 | 393 | 5 | 396 | ||||||||||||
| Total other (expense) income | (1,341 | ) | 354 | (1,693 | ) | (282 | ) | |||||||||
| Net loss before provision for income taxes | (16,703 | ) | (1,695 | ) | (22,120 | ) | (6,029 | ) | ||||||||
| Provision for income taxes | (465 | ) | - | (465 | ) | - | ||||||||||
| Net loss and comprehensive loss | $ | (16,238 | ) | $ | (1,695 | ) | $ | (21,655 | ) | $ | (6,029 | ) | ||||
| Net loss per common share - basic and diluted | $ | (5.30 | ) | $ | (2.93 | ) | $ | (14.96 | ) | $ | (11.12 | ) | ||||
| Weighted average number of common shares outstanding during the period - basic and diluted | 3,061,488 | 579,229 | 1,447,469 | 542,036 |
Non-GAAP Financial Information
To provide investors with additional information
regarding the Company's financial results, we have provided within this press release Adjusted EBITDA, a non-GAAP financial
measure. We define Adjusted EBITDA as net loss adjusted to eliminate (i) stock-based compensation expense, (ii) interest expense,
(iii) interest and other income, (iv) amortization of intangible assets, (v) depreciation expense, and (vi) the provision for income
taxes. We have provided a reconciliation below of Net Loss and Comprehensive Loss, the most directly comparable GAAP financial
measure, to Adjusted EBITDA.
We have included Adjusted EBITDA in this
press release because it is a key measure used by our management to understand and evaluate our core operating performance and
trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe
the exclusion of certain items from net loss in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons
Accordingly, we believe that Adjusted EBITDA
provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted EBITDA has
limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as
reported under GAAP.
The following table presents a reconciliation
of Net Loss and Comprehensive Loss to Adjusted EBITDA for each of the periods indicated:
| For the Three months Ended September 30, | For the Nine months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss and comprehensive loss | $ | (16,238 | ) | $ | (1,695 | ) | $ | (21,655 | ) | $ | (6,029 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,812 | 437 | 3,662 | 1,110 | ||||||||||||
| Interest expense | 1,346 | 39 | 1,698 | 678 | ||||||||||||
| Interest and other income | (5 | ) | (393 | ) | (5 | ) | (396 | ) | ||||||||
| Amortization of intangible assets | 679 | - | 679 | - | ||||||||||||
| Depreciation | 389 | - | 389 | - | ||||||||||||
| Provision for income taxes | (465 | ) | - | (465 | ) | - | ||||||||||
| Adjusted EBITDA | $ | (11,482 | ) | $ | (1,612 | ) | $ | (15,697 | ) | $ | (4,637 | ) |
Adjusted Cost of Goods Sold ("COGs")
To provide investors with additional information
regarding the Company's financial results, we have provided within this press release Adjusted COGs, a non-GAAP financial
measure. We define Adjusted COGs as Cost of Goods Sold adjusted to eliminate (i) expense related to inventory write down as a result
of excess, obsolescence or scrap, and (ii) the inventory valuation step-up recognized in connection with the July 1, 2025 acquisition
of LNHC Inc. We have provided a reconciliation below of Cost of Goods Sold, the most directly comparable GAAP financial measure,
We have included Adjusted COGs in this
press release because it is a key measure used by our management to understand and evaluate our core operating performance and
trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe
the exclusion of certain items from Cost of Goods Sold in calculating Adjusted COGs can provide a useful measure for period-to-period
comparisons of our business.
The Company accounts for business acquisitions
using the acquisition method of accounting in accordance with Accounting Standards Codification ("ASC") 805, Business
Combinations. ASC 805 requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values,
as determined in accordance with ASC 820, Fair Value Measurements ("ASC 820"), as of the acquisition date. As part
of the July 1, 2025 acquisition of LNHC, Inc., the fair value of the inventory acquired was estimated using the top/down method
that considers the estimated selling price, costs to complete, disposal costs, profit margin on disposal effort, and holding costs.
Significant assumptions include management's estimates for the selling price and the costs to be incurred related to the
disposal effort of the inventory. The non-cash inventory valuation step-up from the acquisition of LNHC Inc. was recognized as
an adjustment to Cost of Goods Sold in the three and nine months ended September 30, 2025.
Accordingly, we believe that Adjusted COGs
provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted COGs has limitations
as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under
The following table presents a reconciliation
of Cost of Goods Sold to Adjusted COGs for each of the periods indicated:
| For the Three months Ended September 30, | For the Nine months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Cost of goods sold | $ | 2,316 | - | $ | 2,316 | - | ||||||||||
| Write-off of inventory | (792 | ) | - | (792 | ) | - | ||||||||||
| ASC 805 Basis Step-Up | (1,111 | ) | - | (1,111 | ) | - | ||||||||||
| Adjusted COGs | $ | 413 | $ | - | $ | 413 | $ | - |
Webcast and Conference Call
Management will host a conference call
today at 8:00 am ET to discuss the Company's third fiscal quarter of 2025 results. Interested parties may participate in
the call by dialing:
(877) 451-6152 (Domestic)
(201) 389-0879 (International)
Conference ID: 13756828
The live webcast will be accessible in
the Investors section of the Company's website or by following the direct link:
(opens in new window or tab)
For those who cannot listen to the live
broadcast, an online replay will be available in the Investors section of Pelthos' website.
About Pelthos Therapeutics
Pelthos Therapeutics is a biopharmaceutical
company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment
burdens. The company's lead product ZELSUVMI (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum,
was approved by the U.S. Food and Drug Administration in 2024. More information is available at www.pelthos.com. Follow
Pelthos on LinkedIn and X.